Status:
UNKNOWN
Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them fro...
Detailed Description
OBJECTIVES: Primary * Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followe...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas
- Locally advanced, nonresectable disease
- Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery
- No visceral or peritoneal metastases
- No adenocarcinoma of the bile ducts or the ampulla of Vater
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Stable or controlled pain with analgesics
- Not pregnant or nursing
- Neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times normal OR \< 3 mg/dL
- Creatinine clearance ≥ 40 mL/min
- Bilirubin ≤ 1.5 times normal
- Alkaline phosphatase \< 5 times normal
- No medical condition that would preclude study treatment
- No active infection
- Negative pregnancy test
- No serious cardiac or respiratory disease
- No uncontrolled or persistent hypercalcemia
- No pre-existing neuropathy
- No biliary or gastro-duodenal obstruction
- No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder
- No familial, social, geographical, or psychological condition that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)
- At least 2 months since prior radiotherapy
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00275119
Start Date
November 1 2003
Last Update
February 9 2009
Active Locations (11)
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1
Institut Sainte Catherine
Avignon, France, 84082
2
Hopital Saint Andre
Bordeaux, France, 33075
3
Clinique Tivoli
Bordeaux, France, F-33000
4
Hopital Drevon
Dijon, France, 21000